Insertion Device with Horizontally Moving Part

ABSTRACT

The invention relates to an insertion device comprising—a penetrating member ( 50 ) connected to transformation means ( 52 ),—a moving part ( 38 ) comprising guiding means ( 39 ) which guiding means ( 39 ) restrict the movement of the transformation means ( 52 ) and guide the penetrating member ( 50 ) from a first to a second position in a first direction, i.e. the direction of insertion, towards the injection site, and—a stationary housing ( 30 ) comprising guiding means ( 32 ) which guiding means ( 32 ) restrict the movement of the moving part ( 38 ). The guiding means ( 32 ) guide the moving part ( 38 ) in a second direction which is linear and different from the first direction i.e. the direction of insertion.

TECHNICAL FIELD OF THE INVENTION

The invention concerns an insertion device for inserting a medicaldevice or a part of medical device into the subcutaneous orintramuscular area of a patient.

BACKGROUND OF THE INVENTION

An insertion device (also called inserter or injector) is commonly usedin the medical field for inserting medical devices, such as infusionsets and the like, through the skin of a patient in a more or lessautomated fashion.

Commonly, when using an inserter, the user, i.e. the patient or thetreatment provider (e.g. nurse, doctor, relative, or the like) has toapply a force towards the surface of the skin of the patient in order toprovide injection of the medical device (needle, cannula, sensor, andthe like). This can cause physiological or psychological distress and/ordiscomfort, and may lead to inappropriate application of the medicaldevice. Many people are afraid of sharp objects, such as injectionneedles and other penetrating devices, commonly used for medicaltreatment and therapy. This fear is often irrational, and it may hamperan appropriate medical treatment. For example in the case ofself-medication, a lack of administration of an appropriate dose of arequired medical composition can lead to complications, which may evenbe life-threatening. When treating diabetes, e.g. in juveniles, there isa risk that the required insulin-dose may not be self-administered dueto irrational fear of the insertion needle, combined with a general lackof knowledge and awareness concerning the consequences of omitting thecorrect application of the device and dosage.

A further known issue with insertion of medical devices is the risk ofcontamination of the penetrating member before or during application.This can easily lead to the introduction of an infection to a patient,e.g. through a contaminated insertion needle. The longer such a needleis exposed, the higher the risk of accidental contamination, e.g. bytouching the needle with a finger, bringing the needle in contact withan unclean surface, or by airborne contamination, aerosol contaminationand the like. Depending on the nature of the contamination (e.g.comprising virus, bacteria, fungus, yeast and/or prion) combined withthe general health status of the patient, the resulting infection canrapidly turn into a life threatening situation.

Finally, it is well known that contact with an infected, used needleespecially in hospital environments can be life-threatening, and therisk of accidental exposure to contaminated material in the form of aused insertion needle must be minimized.

The document WO 2002/002165 discloses a needle device having a needleretraction mechanism retracting the needle upon removing the device froma skin surface. The needle device comprises a penetrating member Nconnected to transformation means (44), an actuator (40) comprisingguiding means restricting the movement of the transformation means andguiding the penetrating member N from a first to a second position inthe direction of insertion towards the injection site. Further, theneedle device comprises a stationary housing (20) provided with guidingmeans restricting the movement of the actuator (40). The actuator (40)and the attached needle N move in the same direction namely thedirection of insertion. According to the present invention thepenetrating part moves relative to the moving part and the moving partis fully separated from the penetrating part after insertion. This makesit possible to push the moving part in one direction with a simplespring mechanism while the penetrating member is guided to the injectionsite in the insertion direction. Separating the units and the directionoptimises the possibility of individual control of each part when itcomes to e.g. velocity and acceleration.

Thus, there is an obvious need in the art for a robust, reliable,accurate, safe, hygienic, and user friendly insertion device, whichaddresses the issues discussed above.

SUMMARY OF THE INVENTION

The current invention provides an insertion device for subcutaneouslyintroduction of a penetrating member, where a “penetrating member” isunderstood to be a needle, a cannula, a sensor or the like. Thepenetrating member is normally prior and during insertion kept in aposition where it is not visible to the patient and where it can not getin contact with the user or the patient before it is actually inserted.

The object of the invention is to provide an insertion device comprising

-   -   a penetrating member connected to transformation means,    -   a moving part comprising guiding means which guiding means        restrict the movement of the transformation means and guide the        penetrating member from a first to a second position in a first        direction, i.e. the direction of insertion, towards the        injection site, and    -   a stationary housing comprising guiding means which guiding        means restrict the movement of the moving part, which guiding        means guide the moving part in a second direction which is        linear and different from the first direction i.e. the direction        of insertion.

According to one embodiment the second direction is perpendicular to thefirst direction but the second direction could be in any angle relativeto the first direction, normally in an angle deviating 40-90° from thefirst direction.

“A stationary housing” means that the housing does not move relative tothe insertion site during insertion. Often the contact between theguiding means restricting the movement of the transformation means andthe transformation means are “sliding”, this indicates that the contactbetween guiding means and the unit to be guided is continuous i.e. it isnot interrupted but keep in contact with the guiding means at allpositions.

According to one embodiment the insertion device comprises guiding meanswhich restricts the movement of the penetrating member to a linearmovement in the first direction. These guiding means assures that thepenetrating member passes into the patients skin in a direction linearto the insertion direction during insertion, the time period defining“during insertion” is the time period which starts when the part of thepenetrating member which is to be inserted into the skin of the patientis just about to penetrate the skin surface at the injection site andends when the part of the penetrating member which is to be inserted isfully inserted. If the guiding means are not present the linear movementwould be assured alone by regulation of the velocity of the penetratingmember which is difficult especially when using simple and non-expensivecomponents.

According to a further embodiment of the insertion device the firstdirection form an angle β to the surface in which the penetrating memberis to be inserted, and where 30°≦β≦90°. The angle β is defined as thedirection which the penetrating member moves in from the time justbefore the penetrating member touches the surface on which it is mountedand until the member is in its final position below the surface. Thismovement is linear. The penetrating member can be inserted at aninclined angle where β: 30°≦β<85° or 95°<β≦150°; normally an inclinedangle will be around 45° i.e. 30°≦β<60° or 120°≦β<150°; or 40°≦β<50° or130°≦β<140°; where said penetrating angle β is defined as the anglebetween the direction of penetrating movement of the penetrating memberand surface on which it is mounted.

According to this embodiment of the insertion device the angle β can beessentially perpendicular to the surface on which it is mounted. Thatthe penetrating direction is essentially perpendicular to the patientsskin surface means that penetrating angle β=90°, normally a smalldeviation from 90° such as 85°≦β<95° would also be consideredperpendicular to the skin surface.

According to a further embodiment of the insertion device the directionof the moving part during insertion is linear and essentially parallelto the surface on which it is mounted. That the direction is essentiallyparallel means that the angle between the direction of the moving partand the mounting surface at the insertion position is around 0°. Therecan be an inclination angle α: −45°<β<45°; wherein a positiveinclination angle a indicates a movement inclined towards the skinsurface, and a negative inclination angle indicates a movement inclinedaway from the skin surface. Normally there will be a deviation <10°,i.e. −10°<α<10°, between the surface of the patient's skin and thedirection of the moving part. That the direction of the movement of themoving part is linear means that the moving part moves from a firstpoint to a second point along a straight line.

According to a further embodiment of the insertion device a furthermovement of the moving part can provide a retraction movement of saidholding means and/or an insertion needle. “A further movement” meansthat after a first movement i.e. the linear movement has ended at asecond point, the forward movement of the moving part can continue to athird point where the forward movement of the moving part is stopped oralternatively the linear movement of the moving part can be reversed ortake a second direction.

According to a further embodiment of the insertion device the insertionpart can attached to a base part which base part can be fastened to thesurface where the penetrating member is to be inserted and thepenetrating member will be brought in contact with the base part uponinsertion.

According to a further embodiment of the insertion device thepenetrating member comprises a cannula, a body holding said cannula andretention means securing the body and the cannula at the surface ofinsertion. The cannula is held unreleasably by the body because thecannula is very small and difficult to handle by itself.

According to this embodiment of the insertion device the retention meanscan interact with interacting means on the base part upon insertion andretain the body of the penetrating member to the base part.

According to a further embodiment of the insertion device the guidingmeans of the moving part comprises a groove in which the transformationmeans of the penetrating member can slide. The groove can be essentiallyV- or U-shaped defining a starting point (22 a), a middle point (22 b)and an end point (22 c) for the penetrating member (50) or at leastparts of the penetrating member (50). Further the slope of the groovefrom the starting point to the middle point together with the velocitywith which the moving part moves forward defines velocity of insertion.The slope of the groove is defined in relation to a coordinate systemwhere the x-axis is placed horizontally i.e. along the surface on whichthe base part is placed and in the direction of the line formed by themoving part's forward movement (the moving part moves along the x-axistowards −∞), the y-axis is placed perpendicular to this surface. In sucha coordinate system the groove will have a negative slop between themiddle point and the starting point and the nominal size of the slopewill influence the velocity of the penetrating member during insertion,the steeper the slope the faster the insertion. The slope or the tangentto the slope if the groove is curved i.e. not a straight line willnormally be between −1 and −2. Further the slope of the groove from themiddle point to the end point together with the velocity with which themoving part (38) moves forward defines velocity of retraction. Thegroove will have a positive slop between the middle point and the endpoint and the nominal size of the slope will influence the velocity ofthe penetrating member during retraction of a separate insertion needleor other parts of the penetrating member, the steeper the slope thefaster the retraction. The slope or the tangent to the slope willnormally be between 1 and 2.

According to a further embodiment of the insertion device the movingpart can be moved as a consequence of either direct or indirect userinput. That means that a user either provides a direct force to thedevice i.e. the user pushes or pulls the moving part or the useractivates a spring or the like which then pushes or pulls the movingpart.

According to this embodiment the insertion device moving of the movingpart can be initiated by activating an activation part and theactivation part is in contact with an energy storing member andinfluences the state of the energy storing member upon activation.Further the energy storing member can be a spring, and said spring is ina relaxed or partially relaxed state before activation and in a biasedor distorted state after actuation of the activation part.

According to this embodiment of the insertion device the energy storingmember provides the energy required for moving the moving part from astart position to a stop position.

According to one embodiment of the insertion device the housing cancomprise retention means retaining the moving part in a start position,the moving part comprises locking means interacting with the retainingmeans in the start position and the activation part comprisesinteraction means interacting with the locking means upon activation.The locking means can be released from a locked position throughinteraction of the interaction means of the activation part. Further thelocking means can have the form of a hook provided with an inclinedsurface pointing in the direction opposite to the forward movement ofthe activation part and the retention means can be a part protrudingfrom the housing which can be caught by the hook formed by the lockingmeans.

According to these embodiments the forward movement of the activationpart is stopped through contact between the interaction means of theactivation part and the retention means for the moving part.

According to one embodiment of the invention the groove is provided witha flexible part (39A) between the starting point (22 a) and the middlepoint (22 b) which flexible part (39A) can move in a direction oppositethe direction of insertion. The flexible part (39A) can have the form ofa protruding pivotable part (39A) having

-   -   a contact surface which contact surface during movement is in        contact with the transformation mean (51) of the cannula part        (7) and pushes the cannula part (7) towards the injection site,        and    -   a non-contact surface opposite the contact surface which        non-contact surface can move into an open room without getting        into touch with other parts.

According to this embodiment the contact surface can have the form oftwo straight lines or flat surfaces connected in an angle n close to thepoint (D) (see FIG. 18 a) where the cannula part (7) makes contact withthe sealing of the surface plate (1), normally 10 degrees<n<45 degrees.

According to a further embodiment of the insertion device the movingpart can be encompassed by the housing.

According to a further embodiment of the insertion device a base partcan be fastened to the mounting surface and the insertion device cancomprise means which means provide fastening of the insertion device tothe base part before insertion and non-fastening of the insertion deviceto the base part upon insertion of the cannula.

According to this embodiment of the insertion device the means providingfastening and releasing of the insertion device from the base partcomprise fastening means releasably locking the housing of the insertiondevice to the base part, and release means releasing the housing fromthe base part after insertion of the penetrating member. The releasemeans can comprise an elastic member in a biased or distorted statewhich upon release of the fastening means pushes the housing of theinsertion device away from the base part. The elastic member can havethe form of a leaf spring which is positioned between the base part andthe insertion device; the leaf spring will be distorted when theinsertion device is locked to the base part.

According to these embodiments of the insertion device the fasteningmeans which releasably lock the housing to the base part can have theform of a hook of a hard material being an integrated part of thehousing catching a corresponding part of the base part. That the hook isan integrated part of the housing means that it forms part of thehousing i.e. it is unreleasably locked to the housing and e.g.constructed as a part e.g. of a wall of the housing.

According to these embodiments of the insertion device the fasteningmeans has the form of one or more protruding parts which protrudingparts fit into corresponding openings in the base part. The one or moreprotruding parts can be removed from the corresponding openings in thebase part by a rotating movement and the insertion device is mounted tothe base part in such a distance from the surface in which thepenetrating member is inserted that the distance allows for a rotatingmovement of the insertion device. The distance from the surface in whichthe penetrating member is inserted is obtained by constructing theinsertion device with an inclining proximal surface which proximalsurface as a result of the rotating movement gets parallel with thesurface in which the penetrating member has been inserted.

According to these embodiments of the insertion device the fasteningmeans can be flexibly connected to the stationary housing. The movingpart can be provided with one or more protruding parts which uponmovement of the moving part get in contact with the flexibly connectedfastening means and through this contact release the insertion devicefrom the base part.

According to a further embodiment of the insertion device the insertiondevice comprises means to perform the following operations uponactuation of an activation part:

-   -   (a) loading of a spring;    -   (b) movement of the moving part from a start position to a stop        position; and    -   (c) transformation of said movement of the moving part to an        insertion movement of a penetrating member, followed by a        retraction movement of a holding means of the penetrating        member.        This embodiment can further comprise means which can:    -   (d) release the housing from the base plate upon insertion of        the penetrating member.

According to these embodiments of the insertion device the housing canbe connected to the base plate via connection means. The connectionmeans can comprise at least one hinge and at least one locking member.

According to these embodiments of the insertion device the housing canbe released from the base plate by interaction of a releasing memberwith a part of a sidewall of the housing. Said part of a sidewall of thehousing can be flexible, and can be twisted (pivoted) in relation to theremaining housing.

According to a further embodiment of the insertion device thepenetrating member has a first position (i), and a second position (ii)relative to the stationary housing, where the penetrating member in thefirst position (i) is fully retracted and does not protrude from thehousing of the insertion device; and in the second position (ii), a partof the penetrating member such as the cannula and/or insertion needleprotrude maximally from the housing (30). The first retracted positionis the position of the penetrating member before insertion and thesecond maximally protruding position is the position of the penetratingmember just as the penetrating member has been fully inserted. Thepenetrating member can have a further third position (iii), where thecannula protrudes maximally from the housing, and the holding meansand/or insertion needle are retracted into the housing and are no longerin contact with the body holding the cannula.

According to these embodiments of the insertion device the body of thepenetrating member in the second position (ii) and in the third position(iii), is retained through interaction of said retention means of thebody with interacting means on a base part.

According to a further embodiment of the insertion device the movingpart can have a first position (i*), a second position (ii*), andoptionally a third position (iii*) in relation to the housing and in thefirst position (i*) and the optionally third position (i*) the guidingmeans via the transformation means hold the holding means in a positionretracted from the patients skin and in the second position (ii*) theguiding means hold the holding means in a position close to or incontact with the patient.

According to this embodiment of the insertion device the moving part isheld in the first position (i*) by retention means unreleasably fastenedto the housing, locking means unreleasably fastened to the moving partand interaction means unreleasably fastened to the activation part.

According to a further embodiment of the insertion device the kitfurther comprises a base part to which base part the insertion device isfastened at least before insertion and a delivery part which can befastened to the base part and form a fluid path to a penetrating memberinserted by the insertion device.

Definitions

“Parallel” or “essentially parallel” as used herein refers to a secondmovement in a direction, plane, item or the like defined in relation toa first or a reference plane or direction which reference plane ordirection has a direction defined as the angle α=0°; and the secondplane or direction deviates at maximum ±10°; normally not more than ±5°from the first or reference direction α.

In the context of the application “horizontal” or “essentiallyhorizontal” means that a movement in a direction, a direction, plane,item or the like is horizontal or essentially horizontal is parallel oressentially parallel to the surface of the skin of a patient as definedabove. For example, the base part to which the insertion device isfastened can be horizontal, or essentially horizontal, parallel oressentially parallel to the skin.

“Perpendicular” or “essentially perpendicular” as used herein refers toa second movement in a direction, a direction, plane, item or the likedefined in relation to a reference plane or direction which referenceplane or direction has a position or a direction in the angle β=0°; andthe second plane or direction deviates between 80-100°; normally between85-95° from the first reference β.

In the context of the application “Transversal” or “essentiallytransversal” can be used interchangeably with perpendicular oressentially perpendicular as defined above.

“Means”: As used herein, the expression means can comprise one or moremeans. This is irrespective, if with respect to grammar, the verbrelating to said means indicates singular or plural.

BRIEF DESCRIPTION OF THE DRAWINGS

A detailed description of embodiments of the current invention will bemade with reference to the accompanying figures, wherein like numeralsdesignate corresponding parts in different figures.

FIGS. 1A-C show a cross section of a first embodiment of an insertiondevice according to the invention in three states: A: before activation;B: just after insertion; C: after retraction of insertion needle.

FIGS. 2A-F show a cross section of a second embodiment of an insertiondevice in six states. A: before activation; B: after activation, C: justafter insertion, D: after retraction of insertion needle, E: afterrelease of inserter housing and F: after removal of insertion devicefrom base part.

FIG. 3 shows a first embodiment of an assembly comprising an insertiondevice according to the invention.

FIG. 4 shows a second embodiment of an assembly comprising an insertiondevice according to the invention.

FIGS. 5A and 5B show the second embodiment of the assembly, in FIG. 5Athe insertion device is mounted on the base part and in FIG. 5B theinsertion device has been removed from the base part.

FIG. 6 shows second embodiment of the assembly without the insertiondevice and having the delivery part separated from the base part A: seenfrom below; B: seen from above; C: seen from above and showing theconnection part of the base part and D: showing the base part alone seenfrom above.

FIG. 7 shows a longitudinal cut through an assembly as shown in FIG.3-6, the cut is placed at the position of one of the fastening means forthe insertion device.

FIG. 8 shows the insertion device without being attached to the basepart.

FIG. 9 shows a third embodiment of an inserter to be used with theassembly in a state before insertion of a cannula part.

FIG. 10 shows the same embodiment of an inserter as FIG. 9 afterinsertion of a cannula part.

FIGS. 11A-C show how the embodiment of the inserter shown in FIGS. 9 and10 are being detached from a base part of an assembly according to theinvention.

FIGS. 12A and 12B show an embodiment of a moving part to be used with anassembly as shown in FIG. 9-11.

FIGS. 13A and 13B show a fourth embodiment of an inserter to be usedwith the assembly in a state after insertion of a cannula part.

FIGS. 14A and 14B show the internal parts of the inserter housing of thefourth embodiment of the inserter.

FIGS. 15A and 15B show an embodiment of a moving part to be used with anassembly as shown in FIG. 13-14.

FIG. 16 shows one embodiment of a penetrating member which can be usedwith the assembly.

FIG. 17 shows a cut-through view of a second embodiment of a penetratingmember which can be used with the assembly.

FIG. 18 a shows an embodiment of a moving part having an increasedtolerance. FIG. 18 b shows how the moving part 38 is viewed in FIG. 18a.

FIG. 19 shows a driving mechanism comprising a flat spring which can beused to drive the moving part forward in any of the illustratedembodiments of the inserter

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1A-1C shows one embodiment of an insertion device 1 for insertinga penetrating member 50 according to the present invention.

The insertion device 1 comprises a housing 30, a base part 100, a movingpart 38 and a penetrating member 50. For clarity, the moving part 38 isrepresented in a semi-transparent fashion. The FIGS. 1A, 1B and 1C showthe penetrating member 50 in three different positions relative to themoving part 38.

The penetrating member 50 comprises holding means 52 holding thepenetrating member 50, transformation means 51 attached to the holdingmeans 52 of the penetrating member 50, a body 24, a cannula 22, and aninsertion needle 53. The cannula 22 is according to this embodiment asoft cannula which needs to be inserted with the help of an insertionneedle 53 which is attached unreleasably to a part of the insertiondevice and not to the penetrating member 50. The cannula 22 is attachedunreleasably to the body 24. Furthermore, the body 24 comprisesretention means 23 for fastening of the cannula 22 to the base part 100when the cannula 22 has been fully inserted. According to thisembodiment the retention means 23 are formed as mechanical hooks whichcan be forced inward i.e. toward the centre where the cannula 22 ispositioned. As the mechanical hooks are fastened to the body 24 in aflexible way the hooks will return to their original position afterhaving been forced towards the centre, the flexibility will normally bedue to the properties of the material used to produce the body, thehooks and the connection formed between them.

In another embodiment of the invention, the penetrating member 50comprises a sensor or both a sensor and a cannula. In a furtherembodiment of the invention, the penetrating member 50 comprises morethan one cannula 22 e.g. a plurality of cannula and/or a plurality ofsensors.

The housing 30 comprises guiding means 32 for the moving part 38 andguiding means 33 for the penetrating member 50. The guiding means 32 forthe moving part 38 according to this embodiment comprises surfaces ofthe inner walls of the housing 30 along which the moving part 38 canslide and the guiding means 33 for the penetrating member 50 comprisesan upright tube-like shape. The moving part 38 is provided withtransformation means in the form of a V-shaped opening which is form tofit closely with the transformation means 51 of the penetrating member50. The housing 30 is releasably connected to the base part 100, and canbe disconnected from the base part 100 after the penetrating member 50has been inserted. When connected, the housing 30 and the base part 100encloses the penetrating member 50, the moving part 38, and the guidingmeans 32, 33 for the moving part 38 and the penetrating member 50,respectively thereby providing a unit.

The base part 100 comprises an opening 101, which is dimensioned toallow passage or entering of the penetrating member 50 or at least apart of it, such as the cannula 22, the injection needle 53 and theretention means 23.

The base part 100 and the housing 30 are normally individual elements,which elements can be separated in a reversible or an irreversiblefashion. According to the present embodiment the opening 101 comprisesinteraction means 102, adapted to interact with the retention means 23of the body of the penetrating member 50. The opening 101 can be closedand/or protected by a seal 121 which seal 121 is either removable or canbe penetrated by the penetrating member 50. The seal 121 can cover alarge area of the base part 100 and if the base part 100 is partlyconstituted by a mounting pad with an adhesive surface the seal 121 canbe a release layer protecting the adhesive surface before use.

The guiding means 32 for the moving part 38 provides a directionalcontrolled movement of the moving part 38 essentially within the housing30. In the depicted embodiment the moving part 38 can move essentiallyparallel, i.e. essentially horizontal relative to the base part 100,guided by the guiding means 32. Such a movement can be characterised asa sliding movement.

The movement performed by the moving part 38 is a longitudinal movement,i.e. a linear movement relative to the housing 30. The means used toinitiate and maintain the movement of the moving part 38 can either beprovided directly by the user i.e. the user pushes or pulls the movingpart 38 or it can be provided by mechanical means such as a spring whichonly has to be activated by the user

The guiding means 33 for the penetrating member 50 which are a part ofor connected to the moving part 38 provide a movement of the penetratingmember 50 in a direction different from the direction of movement of themoving part 38. This feature has at least two advantages: 1. the user'sactions when activating or pushing the moving part 38 is less likely toinfluence the actual insertion of the penetrating member 50, and 2. theinsertion device can be constructed in a smaller and more compactmanner.

According to the embodiment of FIG. 1 the direction of movement of thepenetrating member 50 is essentially perpendicularly to the direction ofmovement of the moving part 38. The guiding means 33 for the penetratingmember can comprise one or more parts which together provides a welldefined track or tube along or in which the penetrating member can slidee.g. the guiding means 33 may comprise a hollow, cylindrical elementfastened to the housing 30, the penetrating member 50 can move insidethe cylindrical element along the longitudinal axis of said cylindricalelement, comparable to the movement of a piston in a cylinder. Such amovement can be described as a sliding movement as the contact betweenthe inner surfaces of the cylindrical element and the outer surfaces ofthe penetrating member 50 provides the guiding. Alternatively, theguiding means 33 of the penetrating member 50 can comprise one or morebars, governing the direction of movement of the penetrating member 50.As seen in FIG. 1, the guiding means 33 for the penetrating member 50according to this embodiment extend from the inner ceiling of thehousing to the base part 100. The guiding means 33 of the penetratingmember 50 is not necessarily attached to the base part 100. The guidingmeans 33 normally e.g. rest against and/or touch and/or are connectedwith the base part 100. In the depicted embodiment, the guiding means 33of the penetrating member 50 is connected to the housing 30 at theinside of the upper surface (“ceiling”), and at one or more side(“wall”) of the housing 30.

The guiding means 39 or the transformation means of the moving part 38for the transformation means 51 of the penetrating member 50 defines atrack. This track extends from a starting point 22 a to a middle point22 b and ends at an end point 22 c. As seen in FIG. 1, this track isV-shaped, or essentially V-shaped. In the depicted embodiment, theguiding means 39 of the moving part 38 are provided as a continuousgrove or through going opening within the moving part 38. The middlepoint 22 b is closer to the base part 100 than the starting point 22 a,and also closer to the base part 100 than the end point 22 c, also, thestarting point 22 a is closer to the base part 100 than the end point 22c.

It is not essential how the starting point 22 a and the end point 22 cvaries relative to each other, i.e. it would be possible to have anembodiment where the end point 22 c is closer to base part 100 thanstart point 22 a or an embodiment where the starting point 22 a and theend point 22 c have the same distance to the base part 100. It shouldthough be assured that the starting point 22 a is placed in a distancefrom the base part which is far enough to keep the end of the cannula 22and the end of a separate insertion needle 53 inside the housing 30before insertion.

According to the invention and as illustrated in FIG. 1A-1C, theinsertion device 1 is adapted to provide:

-   -   (i) a first state (FIG. 1A), where the penetrating member 50 is        in the starting position 22 a, it is fully retracted and does        not protrude from the housing 30 of the insertion device 1, the        moving part 38 is in a start position in the right side of the        housing 30;    -   (ii) a second state (FIG. 1B), where the penetrating member 50        is in the middle point 22 b, the part(s) of the penetrating        member 50 which are to be inserted, such as the cannula 22        and/or an insertion needle 53, fully protrude the housing 30        through the opening 101 in the base part 100, and the moving        part 38 has been moved forward to a middle position relative to        the housing 30. The stationary guiding means 33 of the        penetrating member 50 prevent the penetrating member 50 from        moving in the same direction as the moving part 38 and only        allows a “vertical” movement of the penetrating member 50 i.e.        vertical is here to be understood as being perpendicular to        “horizontal”; and    -   (iii) a third position (FIG. 1C), where the part(s) of the        penetrating member 50 to be inserted still protrude the housing        30, but the transformation means 51 together with the holding        means 52 and the insertion needle 53 are at the end point 22 c        and the insertion needle has been retracted from the injection        site. The moving part 38 has reached the end of its travel to        the left in the stationary housing. In the second position (ii)        and in the third position (iii), the body 24 of the penetrating        member 50 is retained through interaction between the retention        means 23 of the body 24 of the penetrating member 50 and the        interacting means 102 of the base part 100.

As shown, the horizontally forward movement of the moving part 38 istransformed into an insertion movement of the penetrating member 50followed by a retraction movement of one or more parts of thepenetrating member 50. This is achieved by the interaction of theguiding means 39 of the moving part 38 with the transformation means 51of the penetrating member 50.

In the first position (i), the transformation means 51 of thepenetrating member 50 are at the starting point 22 a of thetrack/guiding means 39. When the moving part 38 is moved horizontallyguided by its guiding means 32, the penetrating member 50 is moveddownwards, i.e. “vertically” towards the base part 100. The speed of themovement of the moving part 38 and the slope of the guiding means 39define the speed of the movement of the penetrating member 50, thus thespeed of insertion i.e. the steeper the slope of the guiding means 39are, the shorter time will be used to guide the penetrating member 50from the retracted start position to the inserted position.

In the second position (ii), the transformation means 51 of thepenetrating member 50 have reached the middle point 22 b of the guidingmeans 39. At this point the direction of the slope of the guiding means39 changes from downwards, i.e. towards the base part 100, to upwards,i.e. away from the base part 100. Thus the orientation of the slope ofthe guiding means 39 defines the direction of movement of thepenetrating member 50. Further the forward horizontal movement of themoving part 38 produces a retraction movement of the holding means 52 ofthe penetrating member 50 and the insertion needle 53. If the cannula 22is a hard self penetrating cannula there will be no need of a separateinsertion needle 53 and also there will be no need to perform the lastretraction part of the movement i.e. the last line of the V in the track39 could be left out and the middle point 22 b would be identical to theend point 22 c.

In the third position (iii), the transformation means 51 of thepenetrating member 50 have reached the end point 22 c of the guidingmeans 39, and the holding means 52 of penetrating member 50 and theinsertion needle 53 are fully retracted.

As seen in FIG. 1, the moving part 38 does not protrude the housing 30.The arrow above the figure indicates the direction of movement of themoving part 38.

FIG. 2A-2F illustrates attachments means with an automatic releasefunction. The insertion device 1 comprises a housing 30, a base part100, a moving part 38, an activation part 11, and a penetrating member50. One embodiment of a penetrating member 50 is shown in these figuresbut a penetrating member 50 similar to the penetrating members describedin FIG. 16-17 might also be used. For illustrative purposes means themoving part 38 are represented in a semi-transparent fashion.

The housing 30 comprises guiding means 32 for the moving part 38 whichallows the moving part 38 to move between at least two positions,guiding means 33 for the penetrating member 50 which allows thepenetrating member 50 to move between at least two positions, andguiding means 34 for the activation part 11 which allows the activationpart to move between at least two positions. The housing 30 is attachedto the base part 100. According to this embodiment the attachment isreleasable. The attachment is provided by parts of the housing 30comprising a hinge 35 and fastening means 14 interacting with parts ofthe base part 100, whereby the housing 30 and the base part 100 arereleasably connected. The hinge 35 comprises an at least partly roundedsurface of a wall of the housing 30 which can pivot in relation to thebase part 100 as it is placed in a groove in the base part 100. Thefastening means 14 of the housing 30 interacts with locking means 108 ofthe base part 100.

The letter “b” in FIG. 2C indicates the height of the housing 30 of theinsertion device 1. The height “b” will expediently be in the range of5-100 mm, and normally in the range 10-50 mm or more specifically 20-30mm. The illustrated embodiment is 25 mm. In embodiments where theinserter is not removed after inserted the inserter should be as low aspossible and normally not extend further from the patients skin than thedelivery part 8.

The housing 30 also comprises retention means 31. The retention means 31hold the moving part 38 in a start position by engaging with lockingmeans 28 on the moving part 38. According to this embodiment theretention means further provides a stop for the movement of theactivation part 11.

The guiding means 32 for the moving part 38 provides a directionalcontrolled movement of the moving part 38 in relation to the housing 30.The guiding means 32 are attached to or connected to or an integratedpart of the inner surfaces of the housing 30 and will normally have theshape of longitudinal tracks corresponding to surfaces on the movingpart 38 in order to make it possible for the moving part 38 to slidealong the tracks. In the depicted embodiment, the moving part 38 canmove parallel, i.e. horizontal to the base part 100, guided by theguiding means 32, the movement will normally be a sliding movement in adirection parallel to the surface of the base part 100, i.e. themovement is a longitudinal movement or a linear movement.

The guiding means 33 for the penetrating member 50 which are a part ofor connected to or integrated with the housing 30 provides that thepenetrating member 50 can only be moved in a well defined directionwhich direction is different from the direction of the moving member 38.In the embodiment the direction of movement of the penetrating member 50is essentially perpendicularly to the direction of movement of themoving part 38. The guiding means 33 for the penetrating member 50 willnormally be formed by inner surfaces of the housing 30, e.g. the guidingmeans 33 may comprise the inner surfaces of a hollow, cylindricalelement wherein the penetrating member 50 can move between at least aforward and a retracted position along the longitudinal axis of saidcylindrical element, comparable to the movement of a piston in acylinder. If the penetrating member 50 has a rectangular cross-sectionthe “cylindrical” element should of course be adapted to fit closely tothe cross-section of the actually used penetrating member 50. Such amovement will be a sliding movement as the continuous contact betweenthe inner surfaces of the cylindrical elements and the outer surfaces ofthe penetrating member 50 provides the guiding. Alternatively, theguiding means 33 of the penetrating member 50 can comprise one or morebars, governing the direction of movement of the penetrating member 50.As seen from the figures the guiding means 33 for the penetrating member50 according to this embodiment can extend from the inner ceiling of thehousing to the bottom part 100. The guiding means 33 of the penetratingmember 50 are not attached to the base part 100 but might reach down andtouch it or e.g. provide a support for the base part 100.

The guiding means 34 of the activation part 11 provides a directionalcontrolled movement of the activation part 11 in relation to the housing30. The guiding means 34 are attached to or integrated with the housing30. In the depicted embodiment, the activation part 11 moves in parallelwith, i.e. horizontal to the base part 100, guided by the guiding means34 which according to this embodiment is provided as parts of the innersurfaces of the housing. The guiding means 34 might be formed aslongitudinal tracks leading the activation part 11 in a well defineddirection or simply the inner surfaces of the walls of the housing 30.Such a movement is normally a sliding movement as the guiding means 34and the activation means are in continuous contact while moving inrelation to each other. The movement will normally be a linear movement.The direction of movement of the activation part 11 is according to thisembodiment identical to the direction of movement of the moving part 38therefore the guiding means 34 of the activation part 11 can be the sameas the guiding means 32 of the moving part 38 i.e. on set of guidingmeans 32, 34 provides the well defined and at least partly simultaneousmovement of the moving part 38 and the activation part 11.

The moving part 38 is provided with transformation means 39 providingtransformation of the movement of the moving part 38, which according tothis embodiment is horizontal, into a movement of the penetrating member50 in the insertion direction followed by a movement of at least theinsertion needle of the penetrating member 50 in a direction ofretraction. According to this embodiment the transformation means are inthe form of a protruding cylindrical part 51 on the penetrating member50 corresponding to an open V-shaped track 39 in the moving part 38. TheV-shaped track 39 is sized to fit closely with the protruding part 51 ofthe penetrating member 50 in order to provide a well defined path ofmovement.

The moving part 38 comprises a releasing member 29 providing aseparation of the housing 30, or at least a part of the housing 30, fromthe base part 100 by releasing the fastening means 14 of the housingfrom the locking means 108 of the base part 100. Said release isprovided by interaction of the releasing member 29 with a part of thehousing 30, according to this embodiment it is the inner wall of thehousing 30 opposite the activation means 11 where the linear movement ofthe activation means 11 would end if continued to the inner wall of thehousing 30.

The housing comprises an elastic member 36 which upon release of thefastening means 14 of the housing initiates removal of the housing 30from the base part 100. According to the embodiment shown in FIG. 2 theelastic member 36 is an integrated part of the housing 30 i.e. it isfastened unreleasably to the housing 30. The elastic member 36 is a leafspring unreleasably fastened to the housing 30 at one end and pressedagainst the base part 100 at the opposite end. The flexibility of theelastic member 36 is defined by the material of which it is constructedand the physical dimensions of the material, according to the presentembodiment the elastic member is constructed of the same material as thehousing i.e. a hard plastic and normally formed during molding of thehousing 30, but it could also be constructed of a metal which aftermolding of the housing is fastened unreleasably to the housing 30.

Insertion of the penetrating member 50 using the insertion deviceaccording to the invention 1 is initiated by activation of theactivation part 11. The activation part 11 is activated by pushing thepart towards the housing 30. The activation part 11 comprisesinteraction means 41. The interaction means 41 interacts with theretention means 31 of the housing 30, thereby arresting the forwardmovement of the activation part 11. As can be seen in FIG. 2A, theactivation part 11 protrudes the housing 30 in the depicted,non-activated state. The letter “a” indicates the length of protrusionof the activation part 11 with respect to the housing 30. The protrusionbefore activation of the activation part 11 will normally be in therange of 1-100 mm, or 5-50 mm, or 10-25 mm, or 15-20 mm. In the shownembodiment the protrusion is 17 mm. In another embodiment of theinvention, the activation part 11 does not protrude the housing 30, orprotrudes the housing 30 only marginally.

The insertion device 1 is in a non-activated state before use, such asduring transport or storage.

According to this embodiment a spring 45 is provided between the movingpart 38 and the activation part 11. Normally the spring 45 will be in arelaxed state during storing as this will normally prolong the time theproduct can be stored while still being fully functional, if the spring45 is in a biased state during storing there is a risk that theperformance of the product will rapidly decrease. As illustrated in FIG.2A-F the spring 45 can be a spiral spring, comprising two ends: a firstend 46, attached to, or placed in connection with the moving part 38 anda second end 47 attached to, or placed in connection with the activationpart 11. The spring 45 is positioned along the direction of movement forthe activation part 11 which is being parallel to the upper surface ofthe base part 100.

A function of the spring 45 is to provide energy for the penetrationand/or retraction movement of the penetrating member 50 and/or parts ofthe penetrating member 50. If this energy is not provided by a spring 45it has to be directly provided by the user of the device as the userprovides a horizontal movement of the activation part 11 by pushing theactivation part 11 towards the housing 30 and thereby a horizontalmovement of the moving part 38.

The spring 45 of the illustrated embodiment stores energy from themovement of the actuation of the of the activation part 11 as the spring45 is biased through this first movement. During actuation of theactivation part 11 the moving part 38 is stationary. When theinteraction means 41 of the activation part 11 gets into contact withthe locking means 28, the moving part 38 is released from the stationaryposition and moved in a direction defined by the guiding means 32. Theforward movement of the activation part 11 is stopped at the time wherethe interaction means 41 touches the retention means 31 of the housing30. According to the embodiment of FIG. 2 the direction of the movingpart 38 is the same as the forward direction of the activation part 11.When the moving part 38 pushed by the spring 45 hits the inner surfaceof the housing 30, the spring 45 is biased enough to provide energy forthe release of the releasable connection between the fastening means 14of the housing 30 and the locking means 108 of the base part 100. Thisis provided by making the wall or at least a part of the wall of thehousing 30 so flexible that the wall can be bend outward and release thefastening means 14 from the locking means 108 of the base part 100. Whenthe locking connection is released the elastic member 36 pushes thehousing 30 away from the base part 100 and the user will not need pullthe insertion device away from the base part 100.

FIG. 3 shows a first embodiment of an assembly comprising an inserteraccording to the invention together with a medication unit 8. Only theside of the base part 100 can be seen as the whole of the upper surfaceof the base part 100 is covered by the medication unit 8. The medicationunit 8 will normally comprise both a reservoir for medication such asinsulin and delivering parts in the form of pumping means and e.g.dosing means which can see to that the patient has a prescribed dose ofmedication.

The FIGS. 4 and 5A and B show a second embodiment of an assemblycomprising an inserter 10 according to the invention, a delivery part 8and a base part. The base part comprises a surface plate 1 attached to acontact surface. The surface plate 1 is in this embodiment constructedof a molded plastic material and the contact surface is the proximalside of a mounting pad 2 which mounting pad 2 is unreleasably fastenedto the surface plate 1 during manufacturing of the device. “Proximal”means the side or surface closest to the patient when the mounting padis adhered to the patient, “distal” means the end or surface furthestaway from the patient when the device is in a position of use.

FIG. 4 shows the embodiment of the assembly seen from the side and FIG.5 shows the same embodiment seen from above. The penetrating member ofthis embodiment is comprised in a cannula part 7 which is inserted intoan opening 12A of a connector part 3 of the base part, this cannulaopening 12A provides and opening which extends right through the basepart. The cannula part 7 is provided with a penetrating member in theform of a cannula 22 which will penetrate the surface of the skin of thepatient during the insertion and be positioned sub- or transcutaneously.

The inserter 10 holds the cannula part 7 before insertion and theinsertion is initiated by pushing a handle 11. FIG. 5 shows thedirection the handle 11 has to be pushed in order to initiate insertionof the cannula part 7. After insertion a not shown insertion needle canbe retracted to the inside of the inserter 10, afterwards the inserter10 can be removed from the base part, leaving an inserted cannula 22fastened to the surface plate 1. If the cannula 22 of the cannula part 7is a hard self penetrating cannula there will be no separate insertionneedle and therefore no need to retract the insertion needle.

The connector part 3 is kept in position by the surface plate 1.According to one embodiment the surface plate 1 and at least an outercover of the connector part 3 is simply molded in one piece duringmanufacturing of the device. The connector part 3 forms a fluid pathbetween e.g. a reservoir 6 of medication or a reservoir for liquidcollected from the patient and a cannula part 7. Therefore the connectorpart 3 is provided with at least two openings, one opening at each endof the fluid path where the first opening 13 is an inlet or outletopening receiving or delivering fluid to a reservoir 6 and the secondopening 12 is an inlet or outlet opening receiving or delivering fluidto a cannula part 7 (see FIG. 6C-D). The connection part 3 might beprovided with extra openings e.g. for injection of a second medicationor nutrient or for letting the fluid in the fluid path get in contactwith a sensor. In order to secure a fluid tight connection between theoutlet opening 12 in the connection part 3 and the cannula part 7 theoutlet opening 12 of the connection part 3 is provided with an elasticsealing 18 around the outlet opening 12. When the cannula part 7 isinserted it will be press fitted into the cannula opening 12 and theelastic sealing 18 will provide a completely fluid tight gasket aroundthe corresponding openings 12 and 20. In order to improved thepress-fitting and thereby the fluid tight connection between the cannulapart 7 and the outlet of the fluid path, the cannula opening 12A can beprovided with a decreasing cross-section in a plane parallel to thecannula 22 when inserted and perpendicular to the surface where theoutlet of the fluid path is positioned. The cannula part 7 will have acorresponding decreasing cross-section.

In the following the first opening 13 will be referred to as “inlet” andthe second opening 12 will be referred to as “outlet” although thedirection of the flow through the fluid path is not significant for theinvention.

The connection part 3 is further provided with a cannula opening 12Awhich accurately fits around a cannula part 7 i.e. the cannula opening12A has the same shape or profile as the cannula part 7 and is just bigenough to let the cannula part 7 pass through and then fit into theopening. When the cannula part 7 is fully inserted into the base partand the patient, then the upper surface i.e. the distal surface of thecannula part 7 is normally at level with or at a lower level than theouter surface of the connection part 3 surrounding the cannula opening12A. When the cannula part 7 has been fully inserted into the connectionpart 3, then an opening 20 in a side surface of the body of the cannulapart 7 corresponds to the opening 12 of the fluid path of the connectionpart 3 and fluid can flow from one part to the other.

FIG. 5B shows the embodiment of FIG. 5A where the inserter has beenremoved. FIG. 5B shows the device from the end which was covered by theinserter 10 before it was removed. From this end it is possible to see apart of the fastening means 14 which assure attachment of the inserter10 to the base part before insertion. According to this embodiment thefastening means 14 comprise two openings 14L and 14R in the connectorpart 3. These openings correspond to two protruding parts 14PL and 14PR(see FIGS. 7 and 8) which protrude from the side of the inserter housingturned towards the base part and the connector part 3 with thecorresponding opening. When the fastening means 14L and 14R on the basepart is engaged with the corresponding fastening means 14PL and 14PR onthe inserter 10, the inserter 10 is prevented from moving in relation tothe base part, at least in the direction perpendicular to the surfaceplate 1. After insertion of the penetrating member where the penetratingmember has been fully inserted into the base part, the inserter 10 canbe removed or detached from the base part. When detaching the inserter10 from the base part, the inserter 10 is moved in a directionhorizontal to the patients skin i.e. the base part is not subjected to aforce perpendicular to the patients skin i.e. a force pulling the basepart away from the patient. Alternatively it would be possible to e.g.glue the inserter to the delivery part 8 before insertion alongadjoining surfaces between the inserter 10 and the delivery part 8 whichsurfaces should be essentially perpendicular to the patient's skin inorder to create a pull in a direction parallel to the patients skin whenthe inserter 10 is removed from the delivery part 8.

FIGS. 6A-D show the base part and the delivery part in a separatedposition from different angles. In FIG. 6A the two parts are shown frombelow. This view shows an opening 12B through which the penetratingmember 7 can be inserted through the base part and through which opening12B the cannula 22 extends. From this view it is possible to see how thereservoir 6 can be positioned in the delivery part 8 and to see how twoopposite positioned release handles 9 are placed at the edge of thedelivery part 8. Further a longitudinal track corresponding tolongitudinal raised guiding means 4 on the base part can be seen.

The two release handles 9 are formed as s-shaped bands where one end isfastened hinge-like to the housing of the delivery part 8 and the firstcurve in the s-shape is slightly extending the outer surface of thehousing of the delivery part whereas the second curve is free i.e. notattached to the housing of the delivery part 8 and is provided with ahook-like shape which can fold around a part 15 protruding from thedistal surface of the base part. When the delivery part is locked to thebase part both release handles 9 are folded round a protruding part 15,when the delivery part 8 is to be removed from the base part, the twoopposite release handles 9 are pushed together whereby the hook-likeparts of the release handles 9 are released from the protruding parts 15of the base part, and the delivery part can be moved backwards i.e. inthe direction away from the cannula part 7 and removed from the basepart in this direction.

In FIG. 6B the two parts are shown from above. This view shows how thedelivery part 8 of this embodiment can be joined to the base part bypushing the delivery part 8 down toward the guiding means 4 which inthis case is a longitudinal raised platform having e.g. a metal lining 5fastened to the top surface. The delivery part 8 is provided withcorresponding means e.g. comprising a track corresponding to the raisedplatform 4. The corresponding means of the delivery part 8 can slidealong the metal lining 5 of the raised platform 4 in the longitudinaldirection. When the delivery part 8 arrives at its working position, thetwo release handles 9 engage respectively with the two protruding parts15 protruding from the upper surface of the surface plate 1. When thedelivery part 8 is in its working position it is locked in allhorizontal directions by the release handles 9. The locking mechanismsmake it possible to fasten and release the delivery device from the basepart as often as needed i.e. a single-use base part can be combined witha multi-use delivery part.

In FIG. 6C the two parts are shown from the end opposite of where theinserter was fastened before insertion of the penetrating member. Fromthis side it is possible to see the inlet opening 13 in the connectionpart 3 through which e.g. medication from the reservoir 6 can enter, theinlet opening 13 is protected with a membrane to prevent contaminationwith microorganisms. According to one embodiment the connection part 3is provided with both a connector needle (not shown as it is placedbehind the bubble shaped membrane) and a bubble shaped self closingmembrane 17 and the reservoir 6 can be provided with a bubble shapedself closing membrane. Hereby a fluid path is established providingtransfer of medication e.g. insulin or nutrients from the reservoir tothe connector part 3. As both parts are provided with self closingmembranes it will be possible to separate the two units from each otherand rejoin them at a later time without the connection part 3 andthereby the patient being contaminated.

FIG. 7 shows a longitudinal cut through an assembly as shown in FIG.4-6. From this view it is possible to the how the fastening means 14 ofrespectively the connector part 3 of the base part and the inserter 10are joined together.

FIG. 8 shows the inserter 10 removed from the rest of the assembly. Fromthis side it is possible to see the fastening means 14PR and 14PL of theinserter.

FIGS. 9-11 show a third embodiment of an inserter, in FIGS. 9 and 10 theinserter is shown separated from the rest of the assembly. The inserter10 comprises like the first and second embodiment of the inserter anactuator handle 11 which in FIG. 9 is shown in a pre-insertion state andin FIG. 10 is shown in an after-insertion state. The third embodiment ofthe inserter is provided with a moving part 38 as shown in FIG. 12 andthis moving part is provided with a protruding member 38A which is anintegrated part of the moving part 38. The moving part 38 is shown twodifferent views in FIGS. 12A and 12B. That it is “an integrated part”means that it moves simultaneously with the moving part and ispositioned stationary in relation to the moving part. Normally it willbe molded together with the moving part and be of the same material, butit can also be made of a different material and attached to the movingpart 38 after the moving part 38 has been produced.

The protruding part 38A on the moving part 38 is provided with a ramp.The ramp is an inclined surface placed on the forward side of theprotruding part 38A in such a way that the front profile of theprotruding part 38A forms an arrowhead.

The fastening means of this embodiment comprises a hinged part 14 whichin this embodiment is fastened to the housing of the inserter 10, thehinged part could alternatively be fastened to an internal part of theinserter e.g. the same part as the protruding parts 14PL and 14PR isfastened to. In the shown embodiment the hinged part 14 is actually madeas a part of the housing as the hinged part 14 is created by making twocuts in the full height of the housing. The housing is normally made ofa hard, molded plastic such as polypropylene and the relatively longshape of the hinged part 14 makes it very flexible i.e. the hinged part14 is very pliant and it will be easy to push it outward from therelaxed position, the inward movement is blocked by the presence of theguiding means 33 for the penetrating member which in this embodiment isa cannula part 7. The hinged part 14 can also be made of a materialwhich is different from the material of the housing of the inserter e.g.metal which are then attached to the housing in a rotatable manner.

The hinged part 14 is provided with two inward hooks (“inward” meansthat the hooks point toward the inside of the housing) at the lower orproximal end of the hinged part 14 and the two hooks lock the housing tothe base part by catching a stationary protruding part 14B of the basepart. As the two hooks are turned inward they are released from theirlocked position by being pushed outward i.e.

away from the centre of the housing. The hinged part 14 is also providedwith a contact member 14A having the form of a rounded plate of a rigidmaterial placed inwards from the hinged part 14 around the guiding means33 for the cannula part 7. When the moving part 38 moves from its startposition to its end position the protruding member 38A which is placedon the trailing edge of the moving part 38 will hit the contact member14A with the ramp surface and the contact member 14A will be forcedoutward and so will the hinged part 14 as the contact member 14A isattached unreleasably and rigidly to the hinged part 14.

The housing of the inserter also comprises two protruding parts havingthe form of rounded hooks 14PL and 14PR on the inside surface of thewall opposite the inward hooks of the hinged part 14. These protrudingparts 14PL and 14PR fits into corresponding openings 14L and 14R of thebase part close to the connector part 3. The openings in the base partare shown in FIG. 16A. When the fastening means in the form of theopenings 14L and 14R on the base part is engaged with the correspondingfastening means in the form of the rounded hooks 14PL and 14PR on theinserter 10, the inserter 10 is prevented from moving in relation to thebase part, both in the direction parallel to the longitudinal directionof the base part as the protruding parts are rounded and form a griparound the opening, and also in the direction perpendicular to thesurface plate 1 due to the insertion of the protruding part into theopening. After having fully inserted the penetrating member (FIG. 10),the inserter 10 can be removed or detached from the base part.

In order to detach the inserter 10 from the base part, the inserter 10is pivoted around an axis provided along the upper surface of theopenings 14L and 14R. The upper (distal) surface of the openings 14L and14R provide a contact surface for the rounded hooks 14PL and 14PR alongwhich contact surface the downward contact surface of the rounded hooks14PL and 14PR can slide and thereby be forced out of the openings 14Land 14R when subjecting the inserter housing 30 to a rotationalmovement. After insertion the base part comprising the surface plate 1and the inserted part 7 is completely stationary in relation to thesurface in which the cannula or sensor has been inserted and therotational movement is only provided by the inserter 10.

The rotatable movement is made possible at the lower or proximal surfaceof the housing of the inserter is inclined in relation to the uppersurface 1 of the base part and therefore leaves room for thedisplacement of the housing 30, at the end of the rotational movementthe lower (proximal), inclined surface of the inserter housing willnormally rest against the patients skin.

FIG. 11A shows the inserter in a position before insertion. In thisstate the inclined lower surface is lifted away from the patient's skin.The inward hooks of the hinged part 14 are locked around the protrudingpart 11 B on the base part.

FIG. 11B shows the inserter after the cannula part has been inserted. Inthis state the inclined lower surface is parallel to the patient's skinand the inward hooks of the hinged part 14 have been released from thelocked position.

FIG. 11C shows the inserter after it has been removed from the basepart.

FIGS. 12A and 12B show the moving part 38 of the third embodiment of theinserter shown in FIG. 9-11. FIG. 12A shows the “back side” i.e. theside turned away from the penetrating member and FIG. 12B shows the“front side” i.e. the side turned toward the penetrating member. Thefigures show the protruding part 38A placed at the trailing edge of themoving part 38 having the inclined side i.e. the ramp facing forward inthe direction of movement, and the figures show the transformation means39 in the shape of a longitudinal opening formed as a V where the startposition is at the upper end of the first line in the V and the endposition for the penetrating member is at the upper end of the secondline in the V.

FIGS. 13 and 14 show a fourth embodiment of an inserter, this embodimentdiffers from the third embodiment by the fastening means 14 securing theinserter to the base part. The inserter 10 is in FIGS. 13 and 14 shownin an after-insertion state where it has been removed from the basepart. The fourth embodiment has means to release to sets of functionallyindependent fastening means which are supporting each other.

Like the third embodiment the fourth embodiment of the inserter isprovided with a moving part 38 (see FIGS. 15A and 15B) having aprotruding member 38A being an integrated part of the moving part 38.The moving part 38 of the fourth embodiment is further provided with asecond integrated part called the positioning means 27. Thesepositioning means 27 are attached to the lower trailing edge of themoving part 38.

The fastening means of this embodiment comprises like the thirdembodiment of the inserter a hinged part 14 which is fastened to thehousing of the inserter 10 and the hinged part 14 moves in the same wayas described for the third embodiment of FIGS. 9 and 10. The hinged part14 of the fourth embodiment is also provided with two inward hooks atthe lower or proximal end of the hinged part 14. The two hooks lock thehousing against the base part by catching a stationary protruding part14B of the base part having a downward or proximal contact surface. Asthe two hooks are turned inward they are released by being pushedoutward i.e. away from the inside of the housing.

The hinged part 14 is also provided with a contact member 14A having theform of a plate placed in a direction toward the centre of the inserteri.e. “inwards” from the hinged part 14 around the guiding means 33 forthe cannula part 7. When the moving part 38 moves from its startposition to its end position the protruding member 38A which is placedon the trailing edge of the moving part 38 will hit the contact member14A with the ramp surface of the protruding member 38A and the contactmember 14A will be forced outward and so will the hinged part 14 as thecontact member 14A is attached unreleasably and rigidly to the hingedpart 14.

According to the fourth embodiment the protruding members 14PL and 14PRare positioned on a flexible member 114. The protruding members 14PL and14PR according to this embodiment have a rectangular profile but couldalso have e.g. a round or triangular profile. The protruding members14PL and 14PR fits into openings 14P and 14L of the base part close tothe connector part 3. These openings correspond to the rectangularprotruding members 14PL and 14PR. When the fastening means in the formof the openings 14L and 14R on the base part are engaged with thecorresponding fastening means in the form of the protruding members 14PLand 14PR on the inserter 10, the inserter 10 is prevented from moving inrelation to the base part, both in the direction perpendicular to thesurface plate 1 and in any direction parallel to the surface plate 1.

The flexible member 114 is attached to the housing or a part beingstationary in relation to the housing 30 in such a way that the flexiblemember can move between two positions, a first position where theinserter is locked to the base part, and a second position where theinserter is released from the base part. Both FIGS. 17A and 17B show theflexible member 114 in a relaxed locked position and an arrow in FIG.17B indicates the direction it moves in, in order to get to the secondreleased position. According to the shown embodiment the flexible member114 is made as an integrated part of the guiding means 32 for the movingpart i.e. the flexible member 114 constitutes a part of the surfaces orwalls along which the moving part 38 slides. The flexible member 114 isprovided with a contact part 115 which according to this embodiment hasa triangular profile with the sharpened edge pointing forward in thedirection of movement during insertion. The contact part 115 is formedwith a ramp shaped surface pointing in the direction opposite of thedirection of movement of the moving part 38 during insertion.

In order to bring the flexible member 114 from a first relaxed andlocked position into a second and released position the flexible has tobe subjected to a force large enough to be able to move the flexiblemember 114 to the second position.

FIGS. 14A and 14B shows the internal parts of the inserter housing 30which provide the guiding parts for the moving part and which are notvisible when the surrounding housing is in place. FIGS. 14A and 14B showidentical cuts through these internal housing parts but in FIG. 14A themoving part 38 is removed in order to make the contact part 115 of theinternal parts visible. The contact part 115 consists of a protrudingramped surface which will get in contact with the positioning means 27of the moving part 38 when the moving part 38 is in its end or finalposition.

FIGS. 15A and 15B show the moving part 38 of the fourth embodiment ofthe inserter shown in FIG. 13-14. FIG. 15A shows the “back side” i.e.the side turned away from the penetrating member and FIG. 15B shows the“front side” i.e. the side turned toward the penetrating member. Thefigures show the protruding part 38A placed at the trailing edge of themoving part 38 having the inclined side i.e. the ramp facing forward inthe direction of movement, and the figures show the transformation means39 in the shape of a longitudinal opening formed as a V where the startposition is at the upper end of the first line in the V and the endposition for the penetrating member is at the upper end of the secondline in the V. The end position is placed lower than the start position.At the lower edge of the moving part 38 is shown positioning means 27which assures the positioning of the moving part 38 in relation to thehousing of the inserter when sliding along the guiding means 32 providedby the surrounding parts of the inserter housing but which main functionis to force the flexible member 114 of the housing “backwards” when themoving part 38 and the integrated positioning means 27 passes by.

When the positioning means 27 of the moving part 38 touch the flexiblemember 114, the flexible member 114 is pushed away from the connectionpart 3 of the base part, and the fastening means in the form of theprotruding parts 14PL and 14PR are pulled out of the correspondingopenings in the base part 14L and 14R. When the moving part 38 is in itsend position, the integrated parts 38A and 27 will be at positions whereboth the hinge part 14 and the flexible member are pushed away fromtheir relaxed and locked position which means it will be possible toremove the inserter from the base part when the moving part 38 is in itsend position.

FIG. 16 shows an enlargement of a cannula part 7 used with theembodiments of FIG. 1-2. This embodiment comprises a body 24 providedwith a cannula 22 and with a protruding front 25 having a flat surfaceprovided with an opening 20. The protruding front 25 of the cannula part7 need not be flat; it can actually have any desired shape as long as itis possible to create a corresponding surface on the connection part 3facing the cannula part 7. In one embodiment the front 25 is inclined insuch a way that the cross-section at the upper i.e. distal end of thecannula part 7 is larger than the cross-section at the proximal end ofthe front, i.e. the end closest to the patient after insertion. Theopening 20 of the protruding front 25 is an inlet or outlet throughwhich liquid can enter or exit the cannula part 7. The body 24 isfurther provided with a top opening 21 which can be covered with a selfclosing membrane. The opening 21 need some kind of entrance protectionas it is facing an outer surface which is in contact with thesurroundings. The top opening 21 is primarily used when inserting thecannula part 7 if the cannula 22 is a soft cannula. That the cannula 22is soft means that it is made of a relatively soft material which cannot by it self penetrate the patients skin, in this case it is necessaryto use a pointy insertion needle of a relatively hard material wheninserting the cannula and this pointy needle can be inserted through thetop opening 21, pass through an inner hollow in the body 24 of thecannula part and further pass through the full length of the cannula 22in such a way that the pointy end of the insertion needle stick out ofthe open end of the hollow cannula 22. After insertion i.e. after thecannula 22 has been placed sub- or transcutaneous in the patient, thenthe insertion needle is retracted and the cannula 22 is left inside thepatient. The cannula part 7 is also provided with fastening means 23which in this embodiment has the form of a series of outward hooks 23which are flexibly fastened to the body 24 in such a way that the hookscan pivot inwards toward the centre of the cannula part 7. When thecannula part 7 is pressed toward the base part, the hooks 23 passes anedge which pushes them toward the centre as they passes the edge andwhen the hooks have passed the edge they return to their originalposition and as a upward surface of one or more of the hooks touch adownward surface of the edge the cannula part 7 is locked unreleasablyagainst the edge.

FIG. 17 shows an enlargement of a second embodiment a cannula part 7.This embodiment also comprises a body 24 provided with a cannula 22 andwith a protruding front 25 having a flat surface provided with anopening 20 but according to this embodiment the protruding front 25 isinclined in order to reduce the force required to insert the cannulapart and in order to reduce distortion of the sealing 18. Theinclination of the front 25 is defined by the angle d between the centreline c of the cannula 22 and a line parallel to the surface around theopening 20. The angle d will be larger than 0° and smaller than 90°,normally d ε]0°, 30°] depending on the diameter of the sealing 18 or[60°, 90°[. The distance d₁ between at the distal end of the surface ofthe protruding part 25, i.e. the end of the cannula part 7 which isfurthest away from the patient after insertion, and the centre c of thecannula part 7 is larger than the distance d₂ between the surface of theprotruding part 25 at the proximal end, i.e. the end closest to thepatient after insertion, and the centre c of the cannula part 7.Normally the distance d₂ will be so small that the proximal end of theprotruding front 25 does not touch the sealing 18 of the connection part3 during insertion.

In one embodiment (not shown) the angle d is close to 90° i.e. d=90°,such an embodiment would in a drawing corresponding to FIG. 11 appear tohave an upward opening 12 of the connection part 3 fitting to a downwardopening 20 of the cannula part 7. This means that the force pushing thecannula part 7 toward the sealing 18 will be close to perpendicular tothe contact surface of the sealing 18 and this will prevent that thesealing is distorted during insertion of the cannula part 7 by thecannula part 7 sliding along the sealing 18. In another embodiment(shown in FIG. 16) d=0° as the protruding front 25 and the centre line care parallel. According to this embodiment the cannula part 7 will be insliding contact with the protruding sealing 18 which can cause thesealing to be distorted.

As according to the embodiment of FIG. 16 the protruding front 25 of thecannula part 7 need not be flat; it can actually have any desired shapeas long as it is possible to create a corresponding surface on theconnection part 3 facing the cannula part 7. Also the opening 20 of theprotruding front 25 can be an inlet or an outlet depending on thepurpose of the cannula part 7. In FIG. 17 which is a cut-through view itis shown how the top opening 21 of the body 24 is covered with a selfclosing membrane 21A. As according to the embodiment of FIG. 10 the topopening 21 is primarily used when inserting the cannula part 7 if thecannula 22 is a soft cannula but the top opening 21 can also be used toinject medication or nutrients other than the primary medication whichcould be e.g. insulin which the patient receive via the opening 20.

This embodiment of the cannula part 7 is also provided with fasteningmeans 23 and in this embodiment the fastening means 23 has the form of aprotruding part 23 on the cannula part 7 which corresponds to a flexiblepart 23A on the stationary base part. The flexible part 23A can bepushed outward as indicated with an arrow at FIG. 17 when the protrudingpart 23 on the cannula part 7 passes during insertion of the cannulapart 7. After insertion the upward surface of the protruding part 23 ofthe cannula part 7 will be locked by the downward surface of theflexible part 23A of the base part and it will not be possible to detachthe cannula part 7 from the base part.

FIG. 18 a shows another embodiment of the moving part 38 which movingpart has an increased tolerance for deviations from the standardinsertion depth. FIG. 18 a shows the “back side” i.e. the side turnedaway from the penetrating member and when placed in an inserter themoving part would moved from the right to the left while the penetratingmember of the inserter stays in a stationary horizontal position inwhich position it moves first down and then up. The figure shows theprotruding part 38A placed at the trailing edge of the moving part 38,and the guiding means 39 for the transformation means placed within theboundaries of the moving part. According to this embodiment the guidingmeans 39 are defined by a cut-out having an outer limit encircling anopen space in which the transformation means 51 of the penetratingmember can move. The guiding means 39 also comprise a pivotable part 39Awhich part can pivot around a stem through which is fastened to the bodyof the movable part 38. The pivotable part 39A provides a flexible upperlimit as the movable part 38 moves from the right to the left accordingto FIG. 18 a i.e. the pivotable parts 39A swings upwards as thetransformation means passes. When the pivotable part 39A has passed thetransformation means 51 of the penetrating member it swings back intoits resting position.

The transformation means 51 has a start position relative to the movablepart 38 at position A. As the movable part 38 moves to the left, thetransformation means 51 of the penetrating member arrive at position Bby sliding along the upper surface of the guiding means 39, at positionB the insertion needle 53 of the penetrating member touches the skin ofthe patient.

At position C the cannula 22 which is joined to or surrounding theinsertion needle 53 touches the skin of the patient.

At position D the sealing start i.e. contact is made between the cannulapart 7 and the surface plate 1, and a retention click can be heard as aninformation to the user that the cannula 22 is in its correct positionand that the retention means 23 on the stationary base part has lockedthe cannula part 7 to the base part.

As the transformation means 51 of the penetrating member passes fromposition A to position D it slides along the lower contact surface ofthe pivotable part 39A. This contact surface drives the penetratingmember down and it is therefore important that the surface is smooth andprovides as little frictional resistance as possible.

At position E the penetrating member should be fully inserted. That thepivotable part 39A can flex allows for the insertion depth to varyslightly i.e. within the range of ±0.5 mm.

At position G the insertion needle 53 is clear of the self closingmembrane 21A which might cover the top opening 21 of the cannula part 7and at position H the insertion needle is in a safe position i.e. theinsertion needle 53 is retracted relative to the housing of theinserter. Normally it will be retracted at least 1 mm relative to thehousing.

As the transformation means 51 of the penetrating member passes fromposition E to position H it slides along the upward contact surface ofthe trail which forms the guiding means 39 of the moving part 38. Thiscontact surface drives the penetrating member back up and it should besmooth and provide as little frictional resistance as possible.

FIG. 18 b shows a view of the moving part 38 seen from the side. Thearrows marked A indicate the side shown in FIG. 18 a.

FIGS. 19A, B and C show an embodiment of a flat spring which can be usedto drive the moving part forward in any of the illustrated embodimentsof the inserter. According to this embodiment a spring 45 is providedbetween the moving part 38 and the activation part 11. Normally thespring 45 will be in a relaxed state during storing as this willnormally prolong the time the product can be stored while still beingfully functional, if the spring 45 is in a biased state during storingthere is a risk that the performance of the product will rapidlydecrease. In this embodiment the spring 45 is a flat spring e.g. made ofplastic material comprising two ends: a first end 46, attached to, orplaced in connection with the moving part 38 and a second end 47attached to, or placed in connection with the activation part 11. Thesecond end of the spring 45 rests on a block 47 a.

The spring 45 of the illustrated embodiment stores energy from theactuation of the of the activation part 11 as the spring 45 is biasedthrough this first movement. A characteristic feature of a flat springis that when the spring is biased it is bending describing a curve, thepresence of the block 47 a and the form of the block i.e. the length ofthe block 47 a ensures that the spring 45 can only bend in one directionwhen it is biased. The not shown housing of the inserter comprisesretention means 31. The retention means 31 can have the form of apivoting arm holding the moving part 38 in a start position by engagingwith locking means 28 on the moving part 38. The locking means 28according to the embodiment illustrated in FIGS. 19A-C has the form ofprotruding part with e.g. a triangular or round profile.

The deformation of the spring 45 due to biasing can be used to releasethe moving part 38 from the locked start position.

FIG. 19A shows the embodiment in a start position. The spring is relaxedi.e. unbiased and the retention means 31 of the housing is in a lockingposition. In order to begin insertion it is necessary for the user opush the actuator 11, by doing this the spring will become biased.During actuation of the activation part 11 the moving part 38 isstationary.

FIG. 19B shows the embodiment in a loaded position. The spring 45 isfully biased and in this fully biased state the spring 45 is curved tosuch a degree that it touches the retention means 31 of the housing andpushes them away from the locking means 28 of the moving part 38 therebyreleasing the moving part 38 from the housing.

FIG. 19C shows the embodiment in a state where the moving part 38 hasbeen moved to its end position. The actuator handle 11 is in the sameposition as in the fully loaded state of FIG. 19B and the retentionmeans 31 of the housing is in an unlocking position. In this state thepenetrating member which was to be inserted will be insertedsubcutaneously and the next step for the user will be to remove theinserter housing from the insertion site.

1. An insertion device comprising a penetrating member comprising aninsertion needle connected to a transformation member, the penetratingmember before and during insertion is attached to a body holding acannula or a sensor the body comprising a retention member securing thebody and the cannula or sensor at a surface of insertion after insertionhas taken place, a moving part comprising a guide member, the guidemember is configured to restrict the movement of the transformationmember and guide the penetrating member from a first to a secondposition in a first direction towards the injection site, and astationary housing comprising a guide member configured to restrict themovement of the moving part, the guide member of the housing isconfigured to guide the moving part in a second direction which islinear and different from the first direction.
 2. An insertion deviceaccording to claim 1, comprising a penetrating member guide thatrestricts the movement of the penetrating member to a linear movement inthe first direction.
 3. An insertion device according to claim 2,wherein the first direction forms an angle β to the surface in which thepenetrating member is to be inserted, and where 30°≦β≦90°.
 4. Aninsertion device according to claim 1, wherein the direction of themoving part during insertion is substantially parallel to the surface onwhich it is mounted.
 5. An insertion device according to claim 1,wherein the insertion device before insertion of the penetrating memberis attached to a base part, the base part can be fastened to the surfacewhere the penetrating member is to be inserted and the penetratingmember is brought in contact with or passes through the base part uponinsertion.
 6. An insertion device according to claim 5, wherein thepenetrating member is attached to the body holding the cannula the bodycomprising a retention member securing the body and the cannula at thesurface of insertion, the retention member interacts with a connector onthe base part upon insertion and retain the body of the penetratingmember to the base part.
 7. An insertion device according to claim 1,wherein the guide member of the moving part comprises a groove in whichthe transformation member of the penetrating member can slide.
 8. Aninsertion device according to claim 7, wherein the groove issubstantially V- or U-shaped defining a starting point, a middle pointand an end point for at least a portion of the penetrating member.
 9. Aninsertion device according to claim 1, wherein an energy storing memberprovides the energy required for moving the moving part from a startposition to a stop position.
 10. An insertion device according to claim1, wherein the housing comprises a retention member retaining the movingpart in a start position, the moving part comprises a locking memberinteracting with the retention member of the housing in the startposition and an activation part comprises a protrusion interacting withthe locking member upon activation.
 11. (canceled)
 12. An insertiondevice according to claim 11, wherein the locking member comprises ahook provided with an inclined surface pointing in a direction oppositeto the forward movement of the activation part and the retention memberof the housing comprises a part protruding from the housing and isadapted to interact with the hook.
 13. An insertion device according toclaim 10, wherein the forward movement of the activation part is stoppedthrough contact between the protrusion of the activation part and theretention member for the moving part (38).
 14. An insertion deviceaccording to claim 1, wherein a base part is fastened to the mountingsurface and the insertion device comprises a fastener adapted to fastenthe insertion device to the base part before insertion and to releasethe insertion device to the base part upon insertion of the cannula. 15.An insertion device according to claim 14, wherein the fastenercomprises: fastening members releasably leeks locking the housing of theinsertion device to the base part, and release members releasing thehousing from the base part after insertion of the penetrating member.16. An insertion device according to claim 15, wherein the releasemembers comprise an elastic member in a biased or distorted state whichupon release of the fastening member pushes the housing of the insertiondevice away from the base part. 17-20. (canceled)
 21. An insertiondevice according to claim 1, wherein the distance from the surface inwhich the penetrating member (50) is inserted, is obtained byconstructing the insertion device comprises an inclining proximalsurface.
 22. An insertion device according to claim 15, wherein thefastening means members are flexibly connected to the stationaryhousing.
 23. An insertion device according to claim 22, wherein themoving part is provided with one or more protruding parts that contactwith the flexibly connected fastening members and through this contactrelease the insertion device from the base part.
 24. An insertion deviceaccording to claim 1, wherein the insertion device comprises means toperform the following operations upon actuation of an activation part:loading of a spring; movement of the moving part from a start positionto a stop position; and transformation of said movement of the movingpart to an insertion movement of a penetrating member, followed by aretraction movement of a holding means of the penetrating member.
 25. Aninsertion device according to claim 24, further comprising a releasemember adapted to release the housing from the base plate upon insertionof the penetrating member. 26-29. (canceled)